Electronic Instructions for Use in Tanzania: Scope and Duties

1. Key takeaways

Tanzania permits electronic instructions for use (e-IFU), but draws clear boundaries around when they may be used. The 2024 Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment sets the rules in Part VIII §4.1:

a) Who may use it: an electronic IFU is available only for devices reserved for professional users only.

b) Right to a paper copy: users must always be able to obtain the eIFU content in paper form, without undue delay or within the timeframe set in the risk assessment, and at no additional cost.

c) Website marking: for information downloadable from the internet, the internet address must be clearly printed on the physical label of the device and displayed in a way that highlights its purpose to the user; the manufacturer or authorized representative must ensure that the electronic label matches the printed IFU approved through product registration.

d) Risk analysis duty: the manufacturer must conduct and document a risk analysis of the eIFU implementation and retain the record. Three points must be addressed: whether the intended users have the experience and means required to use the electronic IFU (for example, whether a networked computer, a CD/DVD drive, or a compatible web browser is available near the point of use); whether a backup method exists for obtaining the electronic or paper IFU; and whether a process exists to ensure the continued safety of the electronic IFU.

e) Document procedures: the manufacturer must establish clear procedures and processes for the creation and revision of electronic documents.

f) Home-use devices: a paper IFU is mandatory; an additional electronic IFU is optional.

Section 4.2 restates the same rule and names it in the heading as E-IFU for Kiswahili translation for home use device, linking the electronic labelling regime back to the language rules.

2. Legal basis

3. Expert insights

Insight one: the gate for an e-IFU is the user type, not device size or the length of the instructions.

The authority did not adopt criteria such as large equipment or an unmanageably long manual. It draws the line by user: professional users may receive an e-IFU; non-professional (home) users must receive paper. This matches the e-IFU logic of EU MDR Annex I, but the Tanzanian wording is more direct, and it means the classification decision sits in the intended user profile of the device, which should be consistent across the labelling, the IFU, and the registration dossier.

Insight two: the free paper copy is a cost clause, not a service promise.

Section 4.1(b) states at no additional cost. This means that part of the printing budget saved by going electronic must be reserved for answering paper-copy requests. When building the cost model for Tanzania, the paper IFU cost cannot be set to zero, and fulfilment logistics — printing on demand, turnaround times, and distribution through the local channel — should be designed before launch rather than improvised after the first request arrives.

Insight three: changes to electronic labelling also go through the change process and cannot be updated unilaterally.

The Note at the end of §4.1 provides that any change to electronic labelling must follow the requirements of the Guidelines on Submission of Application for Change(s) to Approved Medical Devices and In-Vitro Diagnostics. Read together with TMDA/DMD/MDA/G/003 §3.3, a labelling change involving only layout, colour, font size and design, without altering the prominence of cautions, warnings and contraindications, is a notification-type change that may be implemented and then reported; but once content is touched, it is no longer notification-type and must be submitted for approval beforehand.

Insight four: the three questions of the risk analysis form an auditable checklist.

The three points of §4.1(d) — user experience and means, backup access, continued safety — are not abstract principles but three questions that must be answered in writing. GRZAN recommends a three-column table, with each question answered by evidence, such as a description of the network environment at the point of use, how backup media are provided, and the mechanism used to verify the integrity of the hosted web page. This document becomes the reference during inspections and change assessments alike.

Insight five: home-use devices accumulate a triple duty, including Kiswahili.

For a home-use device, the IFU must satisfy three requirements at once: a paper IFU is mandatory (§4.1(f)); the paper IFU must include Kiswahili (§3.4(a)); and where an electronic version is also provided, the language requirements apply to it as well. This contrasts sharply with professional-use devices, which may operate with an English-only e-IFU. Portfolio owners should therefore separate home-use SKUs early in labelling planning.

4. Practical recommendations

1. Determine the user type first (professional versus lay), then decide whether an e-IFU is available at all.
2. Prepare a paper IFU for every home-use device, treat the electronic version as optional, and include Kiswahili in the paper version.
3. Print the URL on the physical label and run version control that keeps the electronic version identical to the approved printed IFU.
4. Build the e-IFU risk analysis as a three-question evidence table and archive it.
5. Maintain the capacity to supply paper copies on demand, free of charge to the user.
6. Classify any electronic labelling change before implementing it; where in doubt, submit it as a significant or minor change rather than self-implementing it as notification-type.

5. Verification checklist

• □ User type has been determined: professional users only may receive an e-IFU.
• □ The URL is printed on the physical label, and the electronic version matches the approved printed IFU.
• □ A mechanism exists to provide paper copies free of charge (no undue delay, no fee).
• □ The e-IFU risk analysis answers the three questions (experience and means, backup method, continued safety) and is archived.
• □ Home-use devices hold a paper IFU (mandatory); the electronic version is optional.
• □ The home-use device IFU includes Kiswahili.
• □ Electronic labelling changes have been classified under TMDA/DMD/MDA/G/003.

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official TMDA published texts (the June 2024 Compendium Part VIII §3.4, §4, §4.1 and §4.2; TMDA/DMD/MDA/G/003 §3.3) and will be re-reviewed when the regulations are updated.

• Local resources in Tanzania: GRZAN can coordinate a licensed Local Responsible Person (LRP) and distributor resources, covering online submission, sample delivery, quality audit support, and port clearance.
• Service capabilities: classification determination, route selection between registration and notification, technical documentation (CSDT/STED) preparation and localization, GMDN coding and grouping strategy, clinical evidence organization, software and AI-enabled device submissions, change management, vigilance and PMS reporting, and annual retention fee and renewal management.
• Contact GRZAN for registration documentation and conformity support for the Tanzania market: info@grzanglobal.com.